BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 36IN 3-0 S/A FS-1

    MDR report key: 11971516 · Received June 9, 2021

    Report

    Report Number
    2210968-2021-05404
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 1, 2021
    Report Date
    May 12, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031218642
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 07/23/2021. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE EXPLAIN WHAT DOES IT MEAN BY ¿COULD NOT FIND THE CRANIAL ASPECT OF THE KNOT¿. I COMMUNICATED WITH THE VETERINARIAN WHO PERFORMED GIGI'S HERNIA REPAIR AND THEY HAD STATED THEY COULD NOT FIND EVIDENCE OF A CRANIAL KNOT (SUGGESTING THE KNOT WAS NOT INTACT). THEY REPORT FINDING ONE LONG STRAND OF MONOCRYL THAT WAS FIRMLY ANCHORED TO THE KNOT OF THE CAUDAL ASPECT OF THE INCISION. THEY WERE NOT ABLE TO FIND A FRAGMENT ASSOCIATED WITH THE SIMPLE SQUARE KNOT THAT WAS ALSO SECURED ON THE LINEA AT THE TIME OF THE INITIAL SPAY. PLEASE CLARIFY HOW THE SUTURE WAS TIED DURING INITIAL SURGERY (B)(6) 2021? THE LINEA WAS CLOSED USING 3-0 MONOCRYL IN A SIMPLE CONTINUOUS PATTERN. EACH KNOT (CRANIAL AND CAUDAL ASPECT OF SIMPLE CONTINUOUS PATTERN) WERE SECURED USING SURGEON'S KNOTS WITH 4 ADDITIONAL THROWS. AN ADDITIONAL SIMPLE SQUARE KNOT WAS PLACED MIDLINE ON THE LINEA FOR ADDITIONAL LINEA STRENGTH (ROUTINELY PERFORMED TO PREVENT DEHISCENCE OR HERNIATION). COULD YOU PLEASE PROVIDE THE LOT NUMBER? QPMAXK. PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. SUTURE FROM LINEA WAS NOT SAVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO RECEIVE A DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO CLARIFY THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE EXPLAIN WHAT DOES IT MEAN BY ¿COULD NOT FIND THE CRANIAL ASPECT OF THE KNOT¿. PLEASE CLARIFY HOW THE SUTURE WAS TIED DURING INITIAL SURGERY (B)(6) 2021? COULD YOU PLEASE PROVIDE THE LOT NUMBER? PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY VET THAT A CAT UNDERWENT AN OVARIECTOMY/ANIMAL SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. ADDITIONAL MIDLINE SIMPLE INTERRUPTED SUTURE WAS ALSO PERFORMED. ON (B)(6) 2021, A VET DESCRIBED THE LINEA SUTURE AS "RUPTURED" AND WAS NOT ABLE TO FIND THE FRAGMENT FROM THE SIMPLE INTERRUPTED SUTURE. IT APPEARED TO BE A SINGLE STRAND OF SUTURE MATERIAL, AND COULD NOT FIND THE CRANIAL ASPECT OF THE KNOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867298 MCRYL VIO 36IN 3-0 S/A FS-1 SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. Y942G QPMAXK 10705031218642

    Patients

    Seq Age Sex Outcome Treatment
    1